SAN FRANCISCO, CA --(Marketwired - April 13, 2017) - Positive results from RepliCel Life Sciences Inc.'s (
Included in this article is: RepliCel Life Sciences Inc.
RepliCel Life Sciences Inc., on April 4, announced that interim analysis of its Phase 1 study evaluating RCS-01 for sun-damaged and aging skin has produced "statistically and clinically significant positive data." According to the company, the primary objective of the trial was to "establish a complete safety profile for intradermal injections of RCS-01 (RepliCel's type 1 collagen-expressing, hair follicle-derived fibroblasts ["NBDS cells"]) at six months post-injection. Participants in the Germany-based study did not report any serious adverse events at the interim point of the trial. Researchers also gathered compelling positive proof-of-concept data indicating the product's potential for skin rejuvenation."
Although the study was not designed to test efficacy, the company reported that the "nearly two-fold increase in gene expression of collagen-related biomarkers in the skin, after a single injection of RCS-01, was so profound with a single RCS-01 injection, that the results are considered statistically significant."
"This is the most compelling data we have announced to date," stated RepliCel CEO and President, R. Lee Buckler. "Longer term, this data is very complementary to our focus on commercializing a next-generation dermal injector and its targeted application not only with RCS-01, but also with other aesthetic products on the market today. We look forward to discussing these findings and the potential of our products with a number of aesthetic-focused institutional investors and major multinational licensing partners who have already expressed interest in our programs."
Douglas Loe, an analyst with Echelon Wealth Partners, wrote on April 4 that the RCS-01 Phase 1 data "reveals clear biochemical signals that justify further Phase 2 dermatology testing." Loe stated that the skin trial "absolutely met its primary endpoint of demonstrating safety in patients, with no serious adverse events reported at the time of the trial. . . The lack of an observable side effect profile at least reassures us that RCS-01 development can continue Phase II testing unencumbered by any acute safety concerns and we do not expect regulators to see RCS-01 safety profile as an impediment to future studies."
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